90a84031-34db-4a3d-92aa-27fde29be313UpdatePublished22023-06-292018-03-052020-11-03Not in Commercial Distribution08714729974635PrimaryGS1ORISE™M00519540021717889BOSTON SCIENTIFIC CORPORATION1Instrument GuidefalsefalsefalsefalsefalsetruetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse62913Multichannel gastrointestinal endoscopic guide, non-steerableA non-sterile, non-steerable, multi-luminal, flexible tube intended to function as a housing for a compatible flexible endoscope and endoscopic tool(s), to facilitate introduction of the endoscope, and provide independent working channels/insufflation ports (i.e., not through the endoscope) during endoscopic procedures of the gastrointestinal (GI) tract. It includes proximal ports, a flexible shaft, and includes a retracting mechanism to provide a stable endoluminal working space. It may assist in the repeated advancement and withdrawal of the endoscope or endoscopic devices. This is a single-use device.falseActiveFEDendoscopic access overtube, gastroenterology-urologyODBendoscopic contamination prevention sheathGADRETRACTORDevice Size Text, specify60 deg Anglefalsefalse